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References
Pages 231-260

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From page 231...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/ nda/2002/21-373_Ibuprofen%20Pseudoephedrine_biopharmr.pdf (accessed March 23, 2012)
From page 232...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/Development ApprovalProcess/DevelopmentResources/ucm072896.pdf (accessed March 23, 2012)
From page 233...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/ DevelopmentApprovalProcess/DevelopmentResources/ucm074348.pdf (accessed March 23, 2012)
From page 234...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/ 021511s023,103964s5213ltr.pdf (accessed March 23, 2012)
From page 235...
... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric AdvisoryCommittee/UCM272409.pdf (accessed March 23, 2012)
From page 236...
... http://www.ofirmev.com/pdf/OFIRMEVPrescribing Information.pdf (accessed March 23, 2012)
From page 237...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM195520.pdf (accessed March 23, 2012)
From page 238...
... Silver Spring, MD: Food and Drug Administra tion. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022428s000ltr.pdf (accessed March 23, 2012)
From page 239...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/AdvisoryCommittees /CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee /UCM225329.pdf (accessed March 23, 2012)
From page 240...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/Biologics BloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/Fraction atedPlasmaProducts/ucm073064.htm (accessed March 23, 2012)
From page 241...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/RegulatoryInformation/Guidances/ucm127541.htm (accessed March 23, 2012)
From page 242...
... Silver Spring, MD: Science Board, Food and Drug Administra tion. http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_01_FDA%20 Report%20on%20Science%20and%20Technology.pdf (accessed March 23, 2012)
From page 243...
... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/ Drugs/GastrointestinalDrugsAdvisoryCommittee/UCM235453.pdf (accessed March 23, 2012)
From page 244...
... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM195516.pdf (accessed March 23, 2012)
From page 245...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21 598_Vigamox_medr.PDF (accessed April 3, 2012)
From page 246...
... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM073122.pdf (accessed April 3, 2012)
From page 247...
... Silver Spring, MD: Food and Drug Administra tion. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021879s000ltr.pdf (accessed April 3, 2012)
From page 248...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM261988.pdf (accessed April 3, 2012)
From page 249...
... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/Licensed ProductsBLAs/FractionatedPlasmaProducts/ucm134046.htm (accessed April 3, 2012)
From page 250...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21077_Advair%20Diskus _Approv.pdf (accessed April 3, 2012)
From page 251...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_ docs/appletter/2008/021976s009ltr.pdf (accessed April 3, 2012)
From page 252...
... Bethesda, MD: National Institute of Child Health and Human Development. http://bpca.nichd.nih.gov/collaborativeefforts/ upload/pfi_meeting_12062005.pdf (accessed April 3, 2012)
From page 253...
... Silver Spring, MD: Food and Drug Administration. http:// www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric AdvisoryCommittee/UCM198447.pdf (accessed April 3, 2012)
From page 254...
... Silver Spring, MD: Food and Drug Administra tion. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Development Resources/UCM197636.pdf (accessed April 3, 2012)
From page 255...
... Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugs atfda_docs/appletter/2008/125057s114ltr.pdf (accessed April 3, 2012)
From page 256...
... 2011. Clinical review for adenovirus type 4 and type 7 vaccine, live, oral enteric coated tablets biologics license application.
From page 257...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM182634.pdf (accessed April 3, 2012)
From page 258...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm072899.pdf (accessed April 3, 2012)
From page 259...
... 2008. Clinical review for Ventolin HFA (albuterol sulfate HFA inhalation aerosol)
From page 260...
... Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/ Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM201695.pdf (accessed April 3, 2012)


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